Samsung Bioepis Co., Ltd.
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Samsung Bioepis recently broke new ground with the first US approval for a biosimilar with ophthalmic indications. But, senior vice-president and development division leader Kyung-Ah Kim tells Generics Bulletin, there remains work to be done to ensure that ophthalmic biosimilars can meet their full potential.
User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.
Herceptin, Avastin and Rituxan biosimilars have achieved notable market penetration, outpacing other biosimilar launches and contributing to lower drug spending, according to a report from Amgen.
Samsung Bioepis has celebrated the FDA’s first ever approval of an ophthalmic biosimilar with its endorsement of the firm’s Byooviz ranibizumab rival to Lucentis. The firm has also signaled a surprising expected launch date in the US, as well as offering expectations for launch in Europe where the biosimilar was also recently approved.
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